A Phase II Trial of Exploring the Predictive Factors of TX and XELOX Regimen in the First Line Treatment of MGC

Inclusion Criteria:

• Chemo-naive patients with metastatic, unresectable, histologically confirmed gastric or Gastroesophageal adenocarcinoma; Patients who received adjuvant chemotherapy, the duration from the last therapy to relapse at least longer than 6 months
• Patient must have at least one measurable lesions (RECIST 1.1)
• 18 Years to 75 years
• Written informed consent obtained
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Patients must have adequate organ and marrow function as defined below:
• neutrophilicgranulocyte greater than/equal to 1,500/mm3;
• platelets greater than/equal to 90,000/ mm3;
• hemoglobin greater than/equal to 9 gm/dL (may be transfused to maintain or exceed this level);
• total bilirubin less than/equal to 1.5 within institutional upper limit of normal (IULN);
• Aspartate Transaminase (AST,SGOT)/Alanine transaminase (ALT,SGPT) less than/equal to 2.5 times IULN
• serum creatinine less than/equal to 1.5 x IULN.

Exclusion Criteria:

• Active clinically serious infections (> grade 2 NCI-CTC version 3.0, National Cancer Institute-Common Terminology Criteria for Adverse Events)
• Symptomatic metastatic brain or meningeal tumors
• History of organ allograft
• Patients undergoing renal dialysis
• chronic inflammatory bowel disease; ileus; genetic fructose intolerance
• Patients who received adjuvant chemotherapy and the duration from the last therapy less than 6 months
• Receive previously radiotherapy in measurable regions
• Pregnancy or lactating status
• Concurrent malignancy other than nonmelanoma skin cancer, or in situ cervix carcinoma
• Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months
• Acute or subacute intestinal occlusion or history of the inflammatory bowel disease
• Any factors that influence the usage of oral administration